職務說明 / Key Responsibilities
1. Assists with execution of local PV processes and activities in collaboration with internal functional areas and external parties as assigned.
2. Assists with day-to-day adverse events case management including case intake, tracking, translation to English (as applicable), acknowledgments, and follow-up activities in accordance with PV procedures and country regulations.
3. Assists with Individual Case Safety Report (ICSR) Health Authority submissions in accordance with company procedures and health authority requirements, when requested.
4. Assists with aggregate safety report submissions to Health Authorities in accordance with company procedures and health authority requirements, when requested.
5. Participates in compliance activities and assists in coordinating the preparation of necessary corrective actions locally for late reports.
6. Supports local PV audits and inspections when requested.
7. Responsible for reporting adverse experiences or events (AE) or product quality complaints (PQCs) associated with the use of our company products in compliance with Corporate Policy 01: Patient Safety.
8. Responsible for completing all required/applicable trainings assigned at time of hire and after hire by the due dates, before performing the activity.
9. May be assigned responsibility for ensuring appropriate PV language is included in country PV agreements, liaising with Alliance Managers as required, supporting local qualification/due diligence activities and compliance reviews, and assisting in maintenance of the business partner data tracking system.
10. May be assigned responsibility for ensuring appropriate implementation and oversight of Risk Minimization Measures and Additional Risk Minimization Measures locally as per department policy and local legislations.
需求條件 / Key Requirements